Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210379
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 22, 2009
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)

Brief Summary:
The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

Condition or disease Intervention/treatment Phase
Lymphoma, B Cell Drug: rituximab Drug: CHOP Drug: intrathecal methotrexate Procedure: radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma
Study Start Date : November 2000
Actual Primary Completion Date : November 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Disease-free survival
  2. Progression-free survival
  3. Event-free survival

Secondary Outcome Measures :
  1. Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age = 18 years.
  2. ECOG performance status 0-2
  3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
  4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
  5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
  6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
  7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
  8. No previous therapy with monoclonal antibody anti-CD20.
  9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
  10. No other major life-threatening illnesses that may preclude chemotherapy
  11. Have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice

Exclusion Criteria:

  1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2 mg/dl) unless due to lymphoma involvement
  2. HIV positive patients
  3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210379

Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Study Chair: Andreas Sarris, MD International Extranodal Lymphoma Study Group
Study Chair: Emanuele Zucca, MD International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland (IOSI)
Study Chair: Mary Gospodarowicz, MD Radiation Oncology. Princess Margareth Hospital. Toronto
Study Chair: Umberto Vitolo, MD Hematology Division. Ospedale San Giovanni Battista. Torino

Additional Information:
Responsible Party: International Extranodal Lymphoma Study Group (IELSG), IELSG Identifier: NCT00210379     History of Changes
Other Study ID Numbers: IELSG10
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors